Whether you are opening a new facility, seeking an accreditation, or operating business as usual, at some point, you will encounter a third-party organization or regulatory agency. These groups will come on-site for a visit to inspect, survey, or review your operations. Preparation for this on-site visit is the key to a successful outcome.
Steps your business can take to prepare for an on-site inspection, accreditation, or review can include:
- Review Policies and Procedures (P&Ps) to ensure they are consistent with business operations.
- Perform ongoing record reviews to evaluate gaps and areas for improvement.
- Prepare the records or documents that will be needed for your on-site visit and develop a plan to access them efficiently.
- Conduct a mock inspection or survey.
In this article, we will discuss each of the above steps and provide detailed information to help your organization prepare for an inspection, survey, or review.
Review P&Ps
P&Ps must be consistent with laws and regulations, as well as accreditation standards, if applicable. Your policies should accurately describe the expectations of the company and your procedures should accurately describe the steps your employees should take to follow on a particular task, process, or project. Regulatory agencies and accreditation organizations expect a company to adhere to its P&Ps.
Tips for Updating Your P&Ps
Review all P&Ps at least annually to ensure you make any changes that are needed.
When changes in operations occur, be sure to update applicable P&Ps accordingly.
When changes are made to P&Ps, be sure to train all applicable staff on these changes and document the training for employee files.
Perform Ongoing Record Reviews
A great tool to evaluate the status of operations, evaluate gaps, and identify areas for improvement is to conduct a review of your records. You can start by asking the following questions:
- Can you easily retrieve your records?
- Are the records complete? Does the content within the record match your current procedures? Are there any blank areas on any forms that should not be there?
When you identify something is missing on a record during your evaluation, we recommend referring to your P&Ps. Ask the following questions:
- Are there policies or specific procedures about this topic?
- Was the task specified within the procedures?
- Does the procedure have enough detail to offer clear guidance to staff to consistently follow?
After answering these questions, look at the staff training records. Confirm that your staff was trained on this task and talk with your staff about the missing information.
By completing a thorough review of selected records, you can identify gaps and target areas for overall improvement.
Make a Plan and Prepare
A facility that is organized, well-prepared, and “inspection ready” will be equipped to demonstrate a high level of compliance. Depending on the type of on-site visit, there will be specific items the inspector may request. If the reviewing agency provides a checklist of these items or a self-assessment to your organization prior to the on-site visit, use it to prepare. A facility seeking accreditation should review program standards and any relevant P&Ps as part of that preparation. Train key personnel where records may be found quickly, if needed. Have a plan for items that are requested during the onsite visit, but were not pulled in advance. If your organization is mostly using electronic records, make sure you can easily maneuver through the records, create a process to find the records, and train your staff on the process.
Paper Records
If your organization has mostly paper records, you may want to designate a person (or team) that can collect the necessary records during the on-site visit while other items are being reviewed.
Off-Site Records
If your organization has records that are only available at an off-site location, have a plan in place where off-site personnel can be contacted and set up a time for these records to be reviewed later in the day.
Provide training to staff on an ongoing basis during staff meetings. Adding inspection readiness and training as a regular subject will familiarize your staff with these topics and instill confidence in your team. The more confident and prepared your team is, the better your on-site visit outcomes will be.
If you’re interested in obtaining an accreditation, NABP can help. Browse our accreditations page to find information on accreditations we provide to pharmacies, online businesses, and distributors. You can also explore our portfolio of inspection programs to find a program that is right for you. If you’re interested in learning more about how NABP can help your business stay DSCSA compliant, check out Pulse by NABP™.
Continue to Part 2 of this blog post to learn how to conduct mock on-site visits.
All of the ideas listed in this article are intended to be helpful tools for facilities to prepare for an on-site visit. This article does not contain legal advice and should not be construed to be so, nor official NABP Guidance for applicants or accredited facilities. These ideas are not requirements prior to on-site visits.